Law / Hungary

Act XLVII of 1997 on Health Data, Section 35/A(4) to (8), Conditions for AI Development on Electronic Health Service Space Data

1997. évi XLVII. törvény az egészségügyi és a hozzájuk kapcsolódó személyes adatok kezeléséről és védelméről, 35/A. § (4)-(8) bekezdés

In force since .

An AI training data rule binding public and private bodies.

Obligation class
Governance, DPIA

As of .

What it requires

  • Work with EESZT data for AI development only inside the secure processing environment and only with the operator's permit (Section 35/A(4) and (5)).
  • Use only anonymous data, and hold the scientific research permit issued by the competent ethics committee of the Health Science Council (Egészségügyi Tudományos Tanács) (Section 35/A(7)(a) and (c)).
  • Use what you learn during AI development only for that development, and give adequate safeguards against use outside the permit and for the protection of individuals (Section 35/A(7)(b) and (d)).
  • Carry out a data protection impact assessment before AI development starts (Section 35/A(7)(e)).
  • Agree with the operator the conditions for using the data and for making the results available (Section 35/A(8)).

What it makes you log

What the log must hold

Access record

Log retention

Entries are kept for one year.

Unit
Years
As of
Basis
Fixed
Maximum value
1
Minimum value
1

Logging duty

The secure processing environment must log access to it and the activities carried out in it. The duty sits on the environment, which the operator runs, not on the developer.

Kind
Explicit
As of
Provision
Section 35/A(5)(e)
Trigger
personal_data_processing

What this law does

Drafted with AI

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Research summary

Legal information, not legal advice. This is LexLint's own research summary of a public legal source, and it creates no attorney-client relationship. For decisions that matter, consult qualified counsel in the relevant jurisdiction. About LexLint

Section 35/A(4) of the Health Data Act lets the operator of the Electronic Health Service Space (EESZT), on request, permit access to the data stored there for AI development, meaning the training, testing and evaluation of AI algorithms and the development of medical devices and digital health applications. Section 35/A(5) confines that development to a secure processing environment inside the EESZT.

The secure processing environment logs access to it and the activities carried out in it, and keeps the entries for one year. Under Section 35/A(7), AI development in the secure processing environment may be permitted only on anonymous data, and only for a person who holds the permit for scientific research issued by the competent ethics committee of the Health Science Council (Egészségügyi Tudományos Tanács).

That person must ensure that what is learned during AI development is used only for it, guarantee that development uses only anonymous data, give adequate safeguards against use outside the permit and for the protection of individuals, and carry out a data protection impact assessment before development starts. Section 35/A(8) has the operator and the applicant agree the conditions for using the data and for making the results available.

Section 35/A(4) was inserted by Section 25 of Act XXIX of 2024. Section 25 of Act XXIX of 2024 sits in the twelfth subtitle of that Act, which amends the Health Data Act. Section 3(15) of Act XXIX of 2024 puts its twelfth subtitle into force on .

When LexLint raises it

When your app profile says your app trains models.

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